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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 217171

SYFOVRE (PEGCETACOPLAN)
15MG/0.1ML (15MG/0.1ML)
Marketing Status: Prescription
Active Ingredient: PEGCETACOPLAN
Proprietary Name: SYFOVRE
Dosage Form; Route of Administration: SOLUTION; INTRAVITREAL
Strength: 15MG/0.1ML (15MG/0.1ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217171
Product Number: 001
Approval Date: Feb 17, 2023
Applicant Holder Full Name: APELLIS PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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